Sexual and Gender MinoritiesNCT05354284
Physical and Mental Health Among Sexual and Gender Minorities During Pregnancy, Birth and Postpartum
An observational study of Sexual and Gender Minorities and Pregnancy Complications, run by Linkoeping University at 1 site in Sweden.
Trial summary
Mental illness increases the risk of adverse birth outcomes (e.g. preterm birth), obstetric complications (e.g. emergency caesarean, birth injuries), and birth trauma. Sexual and gender minority (SGM) people on average experience increased mental illness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexual and Gender Minorities, Pregnancy Complications, Obstetric Complication
- What is being tested?
- online questionnaire
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2021to Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant LBTQ people
Who may be able to join
- Self defined LBTQ persons
Who cannot join
- age under 18, not able to read Swedish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical and Mental Health Among Sexual and Gender Minorities During
Mental illness increases the risk of adverse birth outcomes (e.g. preterm birth), obstetric complications (e.g. emergency caesarean, birth injuries), and birth trauma. Sexual and gender minority (SGM) people on average experience increased mental illness. Therefore these risks are increased, with risk of prolonged ill health. Despite this, research in this area is scanty. The present project will provide important knowledge for improving the reproductive health of SGM people.
The overall purpose of the project is to increase knowledge about physical and mental health (including fear of childbirth) during pregnancy and postpartum in SGM people. The project has the following aims:
Read more
PART I 2017 - 2021Pilotstudy
- To study fear of childbirth (FOC) among SGM people in Sweden; prevalence and factors associated to FOC
- To investigate reasons to and consequences of FOC in SGM people PART II 2022-2027 Main study
- To explore whether SGM people in Sweden have an increased incidence of mental illness during and after pregnancy, adverse birth outcomes, obstetric complications and birth trauma.
- To explore how pre- and postnatal mental health, minority stress, and fear of childbirth correlate to birth outcomes, birth experience, and obstetric complications in SGM people. This is important for identifying specific risk factors for difficult births, and to explore postpartum health effects.
- To explore in-depth how SGM people have experienced adverse birth outcomes, obstetric complications, and birth trauma, with a specific focus on minority stress and experiences of care during and after pregnancy and childbirth.
Read the detailed description
Mental illness (fear of childbirth included) during pregnancy increases the risk of adverse birth outcomes (e.g. preterm birth, low birth weight), obstetric complications (e.g. emergency caesarean, instrumental birth, major haemorrhage, perineal laceration), postpartum depression, and postpartum PTSD. Further, social vulnerability, such as belonging to an ethnic minority group, has also been shown to increase the risk of these birth-related complications.
It is also well known that sexual and gender minority (SGM) people (e.g. lesbian and bisexual women, transgender and genderqueer people) on average experience increased mental illness. This is thought to be the consequences of exposure to minority stress.
When stressors related to pregnancy and birth are added to the prolonged minority stress, mental illness increases as a consequence. Previous research shows increased depression, anxiety, and feelings of loneliness and dysphoria during pregnancy, as well as increased risk of postpartum depression, in SGM people.
This indicates that SGM people are at increased risk of adverse birth outcomes, obstetric complications, and traumatic birth experiences, followed by an increased risk of long-term negative effects on their mental and reproductive health. There is very little research on these issues. An American study found that incidence of preterm birth, low birth weight, stillbirth, and caesarean are increased among sexual minority women. However, there are no studies on birth outcomes in gender minority people. Nor are there any publications on obstetric complications or birth trauma in gender or sexual minority people. The present project fills these research gaps.
The data of a pilot study in pregnant SGM people shows an increased prevalence in this group. Fear of childbirth increases the risk of obstetric complications, and is a common reason for requested caesarean. There is unpublished clinical data on caesarean in SGM people that shows a huge overrepresentation in this group. Thus, the study preliminary data indicates that SGM people are at risk of adverse birth outcomes, obstetric complications, and birth trauma, and highlights the need for researching these issues thoroughly.
The overall purpose of the project is to increase knowledge about physical and mental health during pregnancy and postpartum in SGM people, as this knowledge is fundamental for improving the reproductive health of this group. The project has the following aims:
PART I 2017 - 2021Pilot study - data collection completed
- To study fear of childbirth (FOC) among SGM people in Sweden; prevalence and factors associated to FOC
- To investigate reasons to and consequences of FOC in SGM people PART II 2022-2027 Main study
- To explore whether SGM people in Sweden have an increased incidence of mental illness during and after pregnancy, adverse birth outcomes, obstetric complications and birth trauma. A register study.
- To explore how pre- and postnatal mental health, minority stress, and fear of childbirth correlate to birth outcomes, birth experience, and obstetric complications in SGM people. This is important for identifying specific risk factors for difficult births, and to explore postpartum health effects. A longitudinal online survey.
- To explore in-depth how SGM people have experienced adverse birth outcomes, obstetric complications, and birth trauma, with a specific focus on minority stress and experiences of care during and after pregnancy and childbirth. A qualitative study
The project will be conducted over three years as a collaboration between researchers at two departments at Linköping University: the Department of Biomedicine and Clinical sciences and the Department of Behavioural Sciences and Learning.
Study 1 is a retrospective register study, where data will be analysed during the first two years. Study 2 is a survey study with two measurements within approximately 6 months. It is important that the survey is launched shortly after the onset of the project, to ensure that a sufficient number of participants are included during the project time. Data from Study 2 will be analysed in the last two years of the project. Interviews for Study 3 will be conducted during the first project year and analysed in the second and third year.
This project will generate a knowledge contribution important for the improvement of reproductive health and rights of SGM people giving birth. The present lack of sufficient knowledge in this area is a barrier for healthcare in developing improved and competent care, and in reducing disparities for pregnant and birth-giving SGM people.
The findings of this project will be useful for healthcare professionals within the fields of reproductive and mental health, and will guide the development of accurate and adequate medical and nursing interventions directed at SGM people. Such interventions can be expected to decrease the incidence of adverse birth outcomes, obstetric complications, and birth trauma, improve care when they do occur, and lower the long-term negative health consequences of such sufferings. The project is important for promoting optimal medical and psychosocial outcomes for pregnant SGM people and their children.
- Conditions
- Sexual and Gender Minorities, Pregnancy Complications, Obstetric Complication, Psychological Trauma
- Being tested
- online questionnaire
- Keywords
- Obstetrical complications, Traumatic birth, Mental and physical health, Pregnancy, Birth, Postpartum
- Medical subject headings
- Coitus, Pregnancy Complications, Psychological Trauma, Birth Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online questionnaireOther
Questionnaire at three timepoints
| Study group | Role | What they receive |
|---|---|---|
| Sexual gender minority people | People self defining Lesbian, Bi-sexual, Transgender, Quer or other are recruited and asked to fill in a questionnaire during pregnancy, three months postpartum and one year later. Receives: Other: online questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIrth experience
Childbirth Experience Questionnaire (1-4 high levels more positive rating)
Measured: 3 moths postpartum
Obstetrical complications
Self report questionnaire
Measured: 3 moths postpartum
Mental illness
Qualitative interviews
Measured: 3 moths postpartum
Obstetrical complications
Qualitative interviews
Measured: 3 months postpartum
Fear of child birth
Wijma Delivery expectancy / experience questionnaire (min 0-max 165. the higher the more severe fear of childbirth)
Measured: At inclusion
Secondary outcomes (5)
Depression
Hospital anxiety and depression Scale ( 0- 21 points per sub scale, high levels worse condition)
Measured: At inclusion, 3 months after birth and 1 year after birth
Anxiety
Hospital Anxiety and Depression Scale (0-21/ sub scale, higher levels worse condition.
Measured: At inclusion, 3 moths after birth and 1 year after birth
Traumatic Birth
City Birth Trauma Scale (0-60 p, high levels means worse condition)
Measured: 3 moths after birth
Life quality
Short Form Health Survey 36, SF 36 ( 0-100 high levels better quality of life/ sub scale)
Measured: At inclusion and 1 year after birth
Posttraumatic stress
Impact of event scale 6 items (0-24, high levels more severe condition)
Measured: At inclusion, 3 moths after birth and 1 year after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Oct 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual and Gender MinoritiesStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anna Malmquist, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354284
- Sponsor's protocol ID
- Reg.nr 2017-499-31
- Status last verified
- Apr 2022
- First submitted
- 2 Feb 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Mental Health Among Sexual and Gender Minorities During
- ClinicalTrials.gov ID
- NCT05354284
- Acronym / sponsor ID
- Reg.nr 2017-499-31
- Conditions
- Sexual and Gender Minorities, Pregnancy Complications, Obstetric Complication, Psychological Trauma
- Keywords
- Obstetrical complications, Traumatic birth, Mental and physical health, Pregnancy, Birth, Postpartum
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mental illness increases the risk of adverse birth outcomes (e.g. preterm birth), obstetric complications (e.g. emergency caesarean, birth injuries), and birth trauma. Sexual and gender minority (SGM) people on average experience increased mental illness. Therefore these risks are increased, with risk of prolonged ill health. Despite this, research in this area is scanty. The present project will provide important knowledge for improving the reproductive health of SGM people.
The overall purpose of the project is to increase knowledge about physical and mental health (including fear of childbirth) during pregnancy and postpartum in SGM people. The project has the following aims:
PART I 2017 - 2021Pilotstudy
- To study fear of childbirth (FOC) among SGM people in Sweden; prevalence and factors associated to FOC
- To investigate reasons to and consequences of FOC in SGM people PART II 2022-2027 Main study
- To explore whether SGM people in Sweden have an increased incidence of mental illness during and after pregnancy, adverse birth outcomes, obstetric complications and birth trauma.
- To explore how pre- and postnatal mental health, minority stress, and fear of childbirth correlate to birth outcomes, birth experience, and obstetric complications in SGM people. This is important for identifying specific risk factors for difficult births, and to explore postpartum health effects.
- To explore in-depth how SGM people have experienced adverse birth outcomes, obstetric complications, and birth trauma, with a specific focus on minority stress and experiences of care during and after pregnancy and childbirth.
Detailed description
Mental illness (fear of childbirth included) during pregnancy increases the risk of adverse birth outcomes (e.g. preterm birth, low birth weight), obstetric complications (e.g. emergency caesarean, instrumental birth, major haemorrhage, perineal laceration), postpartum depression, and postpartum PTSD. Further, social vulnerability, such as belonging to an ethnic minority group, has also been shown to increase the risk of these birth-related complications.
It is also well known that sexual and gender minority (SGM) people (e.g. lesbian and bisexual women, transgender and genderqueer people) on average experience increased mental illness. This is thought to be the consequences of exposure to minority stress.
When stressors related to pregnancy and birth are added to the prolonged minority stress, mental illness increases as a consequence. Previous research shows increased depression, anxiety, and feelings of loneliness and dysphoria during pregnancy, as well as increased risk of postpartum depression, in SGM people.
This indicates that SGM people are at increased risk of adverse birth outcomes, obstetric complications, and traumatic birth experiences, followed by an increased risk of long-term negative effects on their mental and reproductive health. There is very little research on these issues. An American study found that incidence of preterm birth, low birth weight, stillbirth, and caesarean are increased among sexual minority women. However, there are no studies on birth outcomes in gender minority people. Nor are there any publications on obstetric complications or birth trauma in gender or sexual minority people. The present project fills these research gaps.
The data of a pilot study in pregnant SGM people shows an increased prevalence in this group. Fear of childbirth increases the risk of obstetric complications, and is a common reason for requested caesarean. There is unpublished clinical data on caesarean in SGM people that shows a huge overrepresentation in this group. Thus, the study preliminary data indicates that SGM people are at risk of adverse birth outcomes, obstetric complications, and birth trauma, and highlights the need for researching these issues thoroughly.
The overall purpose of the project is to increase knowledge about physical and mental health during pregnancy and postpartum in SGM people, as this knowledge is fundamental for improving the reproductive health of this group. The project has the following aims:
PART I 2017 - 2021Pilot study - data collection completed
- To study fear of childbirth (FOC) among SGM people in Sweden; prevalence and factors associated to FOC
- To investigate reasons to and consequences of FOC in SGM people PART II 2022-2027 Main study
- To explore whether SGM people in Sweden have an increased incidence of mental illness during and after pregnancy, adverse birth outcomes, obstetric complications and birth trauma. A register study.
- To explore how pre- and postnatal mental health, minority stress, and fear of childbirth correlate to birth outcomes, birth experience, and obstetric complications in SGM people. This is important for identifying specific risk factors for difficult births, and to explore postpartum health effects. A longitudinal online survey.
- To explore in-depth how SGM people have experienced adverse birth outcomes, obstetric complications, and birth trauma, with a specific focus on minority stress and experiences of care during and after pregnancy and childbirth. A qualitative study
The project will be conducted over three years as a collaboration between researchers at two departments at Linköping University: the Department of Biomedicine and Clinical sciences and the Department of Behavioural Sciences and Learning.
Study 1 is a retrospective register study, where data will be analysed during the first two years. Study 2 is a survey study with two measurements within approximately 6 months. It is important that the survey is launched shortly after the onset of the project, to ensure that a sufficient number of participants are included during the project time. Data from Study 2 will be analysed in the last two years of the project. Interviews for Study 3 will be conducted during the first project year and analysed in the second and third year.
This project will generate a knowledge contribution important for the improvement of reproductive health and rights of SGM people giving birth. The present lack of sufficient knowledge in this area is a barrier for healthcare in developing improved and competent care, and in reducing disparities for pregnant and birth-giving SGM people.
The findings of this project will be useful for healthcare professionals within the fields of reproductive and mental health, and will guide the development of accurate and adequate medical and nursing interventions directed at SGM people. Such interventions can be expected to decrease the incidence of adverse birth outcomes, obstetric complications, and birth trauma, improve care when they do occur, and lower the long-term negative health consequences of such sufferings. The project is important for promoting optimal medical and psychosocial outcomes for pregnant SGM people and their children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sexual gender minority people | – | Other: online questionnairePeople self defining Lesbian, Bi-sexual, Transgender, Quer or other are recruited and asked to fill in a questionnaire during pregnancy, three months postpartum and one year later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant LBTQ people
Key inclusion criteria (1 listed)
- Self defined LBTQ persons
Key exclusion criteria (1 listed)
- age under 18, not able to read Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online questionnaireQuestionnaire at three timepoints | Other | Sexual gender minority people |
Primary outcome
BIrth experience
Time frame: 3 moths postpartum
Childbirth Experience Questionnaire (1-4 high levels more positive rating)
Obstetrical complications
Time frame: 3 moths postpartum
Self report questionnaire
Mental illness
Time frame: 3 moths postpartum
Qualitative interviews
Obstetrical complications
Time frame: 3 months postpartum
Qualitative interviews
Fear of child birth
Time frame: At inclusion
Wijma Delivery expectancy / experience questionnaire (min 0-max 165. the higher the more severe fear of childbirth)
5 secondary outcomes
Depression
Time frame: At inclusion, 3 months after birth and 1 year after birth
Anxiety
Time frame: At inclusion, 3 moths after birth and 1 year after birth
Traumatic Birth
Time frame: 3 moths after birth
Life quality
Time frame: At inclusion and 1 year after birth
Posttraumatic stress
Time frame: At inclusion, 3 moths after birth and 1 year after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual and Gender Minorities and Pregnancy Complications, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BIrth experience (time frame: 3 moths postpartum). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.